Model Number CI-1601-05 |
Device Problem
Mechanical Problem (1384)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 04/02/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.
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Event Description
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The recipient reportedly experienced decreased performance.A review of the test data indicated impedance issues.Programming adjustments were made, however the issue did not resolve.The recipient's device was explanted.The recipient was reimplanted with another advanced bionics cochlear device.
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Manufacturer Narrative
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Advanced bionics is currently attempting to obtain consent from the recipient.The device remains intact in a locked vault at ab, llc until consent is obtained.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.
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Search Alerts/Recalls
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